11 Nov
|
BIOCON BIOLOGICS
|
Bengaluru
11 Nov
BIOCON BIOLOGICS
Bengaluru
:
1. Maintain the inventory of all Scientific (R&D;) and QC applications/systems at the respective site.
2. Prepare, review, implement, and maintain applicable IT SOPs, procedures, and quality documentation for Scientific and QC systems.
3. Provide IT administration and application support, including user/access management, password administration, active-user reviews, date/time management, event-log reviews, backup, restoration, and data retrieval.
4. Support GxP computerized system qualification and validation, including 21 CFR Part 11 assessments, periodic reviews, and compliance activities from an IT perspective.
5. Coordinate with business teams, Central IT, vendors/OEMs, and service providers for system implementation, breakdown support, troubleshooting, and issue resolution.
6. Manage IT-related incidents, deviations, change controls, RCA, CAPA, and audit observations for Scientific and QC systems.
7. Represent IT during internal, customer, third-party,
and regulatory audits/inspections, including preparation of required documentation, responses, and supporting evidence.
8. Ensure adherence to applicable IT, Quality, GxP, organizational policies, procedures, SLAs, and regulatory requirements.
9. Analyse and support implementation of recent business/application requirements in coordination with cross-functional teams and management.
10. Provide user training and technical guidance during application rollouts and as required.
11. Ensure reliable IT support for business-critical, GxP, regulatory, and product/consumer-safety-related systems and services.
12. Drive service reviews, process improvements, benchmarking, and continual service improvement for Scientific and QC IT services.
Experience: 5-7 years of experience in IT LIMS
📌 IT - LIMS (Bengaluru)
🏢 BIOCON BIOLOGICS
📍 Bengaluru